News Releases

Baker Botts’ Intellectual Property Practice Comments on Biosimilar Mandatory Ruling

Release

NEW YORK, July 6, 2016 - Baker Botts L.L.P., a leading international law firm, today provided comments on the Amgen Inc. v. Apotex Inc. ruling, which was announced by the United States Court of Appeals for the Federal Circuit on, July 5, 2016.

The firm’s Intellectual Property practice sent out an alert on the decision answering pertinent questions related to the case. Read the full alert here.

What is the court’s ruling?

  • The Federal Circuit agreed with the District Court, noting that a biosimilar applicant must provide notice to the reference product’s manufacturer 180 days prior to entering the market, regardless of whether or not the biosimilar applicant chose to comply with the provisions of § 262(l), also referred to as the “patent dance.”
  • The Federal Circuit also disagreed with Apotex’s argument that such a mandatory notice period would effectively extend the reference product’s 12 year exclusivity period by six months.

What does the decision mean?

  • The decision affirmed that compliance with the notice provision is mandatory and enforceable by injunction, regardless of whether the parties had engaged in the patent information exchange pursuant to the patent dance provisions.

Baker Botts' IP practice closely monitors changes to the law and rules of practice to relay important implications the developments have on practitioners and IP owners. Their Intellectual Property Cases to Watch in 2016 alert outlines the wide spectrum of intellectual property issues on the horizon in 2016. Read the full outlook here.

 

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Baker Botts is an international law firm of approximately 725 lawyers practicing throughout a network of 14 offices around the globe. Based on our experience and knowledge of our clients' industries, we are recognized as a leading firm in the energy and technology sectors. Since 1840, we have provided creative and effective legal solutions for our clients while demonstrating an unrelenting commitment to excellence. For more information, please visit bakerbotts.com.

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